Progression free survival and overall survival probabilities over time will be estimated using Kaplan-Meier plots. Their medians with their confidence intervals will be also presented.

Progression Free Survival is measured from first treatment until the date of disease progression or death, whichever is reported first. Subjects who do not progress or die at the time of the analysis will be censored at the day of their last tumour assessment.

Overall survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.

Time to tumor progression [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Patients with intracranial bleeding into metastases allowed provided the disease is well-controlled and not undergoing acute steroid therapy or taper (chronic steroid therapy allowed provided the dose is stable for 1 month prior to and following screening radiographic studies)

No other hemorrhage or bleeding event > CTCAE grade 3 within the past 4 weeks

No serious, nonhealing wound, ulcer (apart from the tumor), or bone fracture

No evidence or history of bleeding diathesis or coagulopathy

No current signs or symptoms of severe progressive or uncontrolled hepatic, hematological, renal, endocrine, pulmonary, or cardiac disease

No known or suspected allergy to sorafenib or any agent given in the course of this trial

No previous cancer that is distinct in primary site or histology from esophago-gastric junction cancer except for carcinoma in situ of the cervix, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis], or any cancer curatively treated > 3 years prior to study entry

No concurrent cancer that is distinct in primary site or histology from esophago-gastric cancer

No substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

No condition that impairs the patient's ability to swallow whole pills

G-CSF and other hematopoietic growth factors allowed in the management of acute toxicity (e.g., febrile neutropenia) when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction

Concurrent chronic erythropoietin allowed provided no dose adjustment is undertaken within 2 months prior to the study or during the study

At least 4 weeks since prior major surgery or open biopsy

At least 4 weeks since prior and no concurrent radiotherapy

Prior or concurrent palliative radiotherapy to symptomatic disease sites allowed (unless the site to be irradiated is one of the target lesions used for response assessment)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158287

Locations

Ireland

Bon Secours Hospital

Cork, Ireland

Cork University Hospital

Cork, Ireland

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital